# K012647: Tonoport V

- Pathway: 510(k) (Abbreviated)
- Applicant: Par Medizintechnik GmbH
- Decided: Nov 9, 2001 after 88 days
- Product code: DXN (System, Measurement, Blood-Pressure, Non-Invasive)
- Device class: 2
- Regulation: 21 CFR 870.1130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K855127 (1986). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964235: Abpm Mobil-O-Graph Blood Pressure Monitor, Model Abp Control, Industrielle Entwicklung Medizintechnik Und Vertri (1999) Summary page 1.

## Most influential descendants
- K170966: Tonoport VI (2017), 0 descendants of its own
- K021029: ABP-2000 G-3 (2002), 0 descendants of its own

## Indications for use
The Tonoport V is a compact, lightweight, patient-borne, non-invasive blood pressure (NIBP) holter using the oscillometric method. The cuff is borne on the upper arm and an electrical pump inside the device generates the pressure in the cuff. The Tonoport V is powered from two AA size batteries (alkaline or rechargeable NiMH batteries). For periods of up to 30 hours it records the patient’s blood pressure at predefined intervals and save the results. In order to assess the measurements, the stored data can be transmitted via a RS-232 interface to a 9-needle dot-matrix printer with serial interface (EPSON LX-300+) or to another medical device for further evaluation or archiving purposes. Tonoport V is intended to be used for measuring the systolic, diastolic, mean blood pressure and the heart rate of human beings for periods up to 30 hours. The intended patient populations are adults and children (but not neonates) with a circumference of the upper arm in the range of 17 cm to 42 cm. Tonoport V is a prescription device in health care medicine. It can be used, if the physical condition of the patient allows an automatic, non-invasive blood pressure measuring under his observation. Medically trained staff like a doctor or nurse, etc should do this judgment as well as the accommodation of the patients and the preparation and application of the Tonoport. The patient does not operate with the Tonoport V by himself. A measurement with Tonoport V is combined with other measurements and medical examinations at the patient, so that a diagnosis about the patient’s health condition depends not alone from the measurement of the Tonoport V. Tonoport V is not intended to be used in home care medicine or in intensive care medicine or for alarming of life-threatening conditions.

Source page: https://510kreport.com/device/K012647
Methodology: https://510kreport.com/methodology